Chance Pharmaceuticals has announced that the Centre for Drug Evaluation of China’s National Medical Products Administration has accepted its new drug application for CXG87, an investigational respiratory therapy for asthma. For a clinical-stage biotechnology company focused on inhalation therapies, the milestone also provides an important test of whether its dry powder inhalation platform can support differentiated respiratory drug development.
CXG87 is a Class 2.2 innovative drug and an improved formulation of budesonide/formoterol powder for inhalation. The therapy has been developed for respiratory diseases such as asthma, with the company positioning it as a formulation designed to reduce the impact of inspiratory flow dependence and improve dosing stability.
The clinical need remains significant. Asthma affects nearly 300 million people globally, while in China, adult asthma prevalence among those aged 20 and above is 4.2 per cent, representing nearly 50 million patients. The outpatient asthma control rate in China is only 28.5 per cent, indicating continued gaps in disease management despite available treatment options.
One persistent limitation in inhaled therapy is that drug delivery can be affected by a patient’s inspiratory capacity. If a patient is unable to generate the optimal inspiratory flow rate required by an inhaler device, lung deposition of medication may be insufficient, potentially affecting treatment response and increasing the risk of exacerbations.
Chance Pharma said CXG87 completed a multicentre, randomised, blinded, positive-controlled Phase III clinical trial in adult patients with bronchial asthma. The study met its primary endpoint of non-inferiority after 42 days of treatment compared with Symbicort Turbuhaler. The company also reported improvements in lung function, favourable trends in asthma symptom relief and exacerbation reduction, and an overall safety profile comparable to the active control.
The company further reported that subgroup analysis in asthma patients with relatively weak inspiratory capacity showed CXG87 may be suitable across a broader range of inspiratory flow rates. This could be clinically relevant for patients whose airflow limitations or reduced lung capacity may affect the performance of conventional dry powder inhalers.
For China’s respiratory therapeutics market, the application reflects a broader push toward refining established inhaled medicines through formulation and device-related innovation. Rather than introducing a new drug class, CXG87 will focus on improving delivery consistency and usability within a recognised therapeutic approach.
The next step will depend on the NMPA review process and whether the submitted clinical and pharmaceutical data support approval. If cleared, CXG87 could become an additional inhaled corticosteroid-formoterol option for asthma patients in China, particularly those who may benefit from a formulation less dependent on inspiratory flow performance.
